Tuesday, June 16, 2015 4:37:44 PM
They may be able to speak about AEZS-130 acceptance in Europe from the same data the FDA looked at, and asked for more. They could also announce what their approach will be for FDA approval. Again, I believe the data's previously been discussed, but the answer to what the FDA wants hasn't been. It's unfortunate, but when the one other drug which had been approved for detecting HGH deficiency was withdrawn from the market, it probably doomed AEZS's proof that their drug gave readings which correlated with that drug. Clearly the maker of the drug saw that AEZS-130 was a superior product, but without that drug, it's extremely expensive and time consuming to prove an HGH deficiency. I'm guessing 99% of the time the Doctor's will give an HGH supplement based on the symptoms rather than running the test. Our drug could clearly be a useful tool for Drs, but it's still only a niche product.
Gary
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